Multi-Point 1.5 Thermal Sensor™ Brief Summary

INTENDED USE

The Boston Scientific disposable Multi-Point 1.5 Thermal Sensor Device (MTS) is a component used in conjunction with a Boston Scientific cryoablation system when performing cryoablative destruction of tissue, to aid the physician’s assessment that the temperatures meet the desired treatment protocol.
It is recommended that the MTS be inserted into strategic locations in the tissue prior to the procedure so the acquired temperature readings -170 °C to 200 °C ± 5 °C (-274 °F to 392 °F ± 9 °F) will provide useful information about the progress of the cryoablation process. These real-time temperature readings can be used to monitor the temperature of the tissue being ablated and to monitor the temperature of tissue not intended to be ablated.

Patient Groups
The intended population includes patients intended for cryoablative destruction of tissue during surgical procedures.

INDICATIONS FOR USE

The Boston Scientific disposable Multi-Point 1.5 Thermal Sensor Device (MTS) is intended for use as an ancillary product when performing cryoablation procedures. Refer to the applicable Boston Scientific cryoablation system User Manual for a complete list of indications for use.

CONTRAINDICATIONS

There are no known contraindications specific to use of the MTS.

WARNINGS

• A thorough understanding of the technical principles, clinical applications, and risk associated with cryoablation is necessary before using this product. Refer to the ICEfx Cryoablation System or Visual-ICE Cryoablation System User Manuals for optional education.
• Do not use this device for any purpose other than the stated intended use.
• Observe the expiration date of this product. Do not use past the listed expiration date.
• Do not use MTS within a Magnetic Resonance Imaging (MRI) suite or environment.
• Use special care to ensure that an MTS does not come into contact with an implanted device.
• MTS needles have sharp tips. Use care to ensure safe handling of an MTS to eliminate the risk of injury or possible exposure to blood-borne pathogens.
• The sterile field and sterility of the MTS should be maintained at all times. Do not contaminate the distal end of the sterile MTS.
• Inspect the packaging for damage. Do not use an MTS if packaging appears opened or damaged; in the event of such occurrence, contact Boston Scientific Technical Assistance Center to arrange return of the complete package with the product.
• Do not use the MTS if it is bent or damaged while attempting to unpack or use it. A defective MTS must never be used and should be returned to Boston Scientific for evaluation.
• Avoid bending the MTS shaft. Do not grasp the MTS with auxiliary instruments as this may cause damage to the sensor shaft.
• During use, avoid damage to the MTS from other surgical instruments.
• Do not kink, pinch, cut or pull excessively on MTS tubing. Damage to handle or tubing may cause the MTS to become unusable.
• Ensure appropriate stability of tubing to avoid inadvertent movement of tubing or MTS shifting during a procedure.
• Prior to starting a cryoablation procedure, set up the cryoablation system (reference the SYSTEM SETUP Section within the cryoablation system User Manual) and then perform the MTS Integrity and Functionality Test. This test must be successfully completed in order to begin the procedure.
• Use Boston Scientific’s MTS to monitor the freeze / thaw temperatures for the intended treatment protocol or to monitor tissue temperature near critical structures.
• Continuously monitor MTS insertion, positioning, and removal using image guidance (such as direct visualization, ultrasound, or Computed Tomography (CT)) to ensure adequate tissue coverage and to avoid damage to adjacent structures.
• In the rare event that an MTS breaks while inserted in the tissue, act immediately to remove sensor parts from the patient’s body and report such event to Boston Scientific.
• Ensure adequate cryoablation needle thawing before attempting to remove an MTS.
• Discontinue all needle operation prior to needle and MTS removal to minimize risk of thermal injury and/or tissue injury.
• Remove MTS from the patient prior to disconnecting the thermal sensors from the cryoablation system.
• Dispose of MTS in accordance with the Disposal Section.

PRECAUTIONS

General

• Boston Scientific MTS operate only with a Boston Scientific ICEfx Cryoablation System or Visual-ICE Cryoablation System.
  

Handling

•  Availability of back-up MTS is recommended should a replacement or additional MTS be required during a procedure

Procedural

• In a safe and controlled fashion, twist the protective sleeve in a rotational motion while simultaneously pulling it away from the device handle. Take extra care when removing the protective sleeve from the device to avoid contact with the distal end of the needle.
• Do not allow the MTS to touch the cryoablation needle during use; erratic temperature measurements may be displayed.
• During a cryoablation procedure, do not immerse the proximal handle or tubing in fluids.
• Do not expose an MTS to organic solvents such as alcohol which may damage the thermal sensor.

ADVERSE EVENTS

The potential adverse events associated with the device and/or cryoablation procedure include, but are not limited to:

• Allergic reaction (contrast, device, other)
  
• Angina
  
• Arrhythmia
• Atelectasis
• Bladder spasms
• Bleeding/hemorrhage
• Burn/frostbite
• Cerebrovascular Accident (CVA)/stroke
• Cryoshock Phenomenon (e.g. multi organ failure, severe coagulopathy, disseminated intravascular coagulation (DIC))
• Death
• Distension
• Edema/swelling
• Ejaculatory dysfunction
• Embolism (air, device, thrombus)
• Erectile dysfunction
• Fever
• Fistula
• Fracture
• Gastrointestinal symptoms (eg. nausea, vomiting, diarrhea, constipation)
• Healing, impaired
• Hematoma
• Hematuria
• Hemothorax
• Hepatic dysfunction/failure
• Hernia
• Hypertension
• Hypotension
• Hypothermia
• Ileus
• Impotence
• Infection/abscess/sepsis
• Inflammation
• Muscle spasm
• Myocardial infarction
• Necrosis
• Need for additional intervention or surgery
• Nerve Injury
• Neuropathy
• Obstruction
• Pain/discomfort
• Perforation (including organ and adjacent structures)
• Pericardial Effusion
• Perirenal fluid collection
• Pleural effusion
• Pneumatosis (air or gas in an abnormal quantity and/or place in the body)
• Pneumothorax
• Post ablation syndrome (e.g. fever, pain, nausea, vomiting, malaise, myalgia)
• Renal insufficiency/failure
• Renal parenchymal or capsule fracture
• Respiratory distress/insufficiency/failure
• Scrotal edema
• Stenosis/stricture
• Subcutaneous emphysema
• Thrombosis/thrombus
• Tissue damage
• Transient ischemic attack (TIA)
• Tumor cell seeding
• Urethral sloughing
• Urinary frequency/urgency
• Urinary incontinence
• Urinary retention
• Urinary tract infection
• Vasovagal response
• Vessel trauma (e.g. dissection, injury, perforation, pseudoaneurysm, rupture, or other)
• Wound infection

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